Digital Air Leak Monitoring for Patients Undergoing Lung Resection

Not Applicable

Completed

• Conditions: Atelectasis; Pneumothorax
• Interventions: Device: Dry suction pleura drainage device; Device: Digital pleural drainage system

• Registration Number: NCT01810172
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. This provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.

Detailed Description

Technology has become a driving force in surgery. From robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. However, new technology comes at a cost to our healthcare system. It is therefore important to ensure that new devices actually improve outcomes. One example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. Unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. Many intra-operative methods have been explored in order to limit this issue with underwhelming success. This is why we are proposing a randomized controlled trial comparing a digital pleural collection system by ATMOS to traditional pleural collection devices by Atrium.

Our research question is: Can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Study Start: 2013-04
• Primary Completion: 2016-04
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Patients 18 or older
• Patients undergoing a lobectomy or segmentectomy

Exclusion Criteria

• Patients under the age of 18
• Patients undergoing pneumonectomy, wedge resection or bullectomy
• Patients who require additional procedures to control intraoperative air leak
• Patients who require mechanical ventilation post-operatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry suction pleural drainage system	Dry suction pleura drainage device	The control group will have their chest tube connected to a dry suction pleural drainage system The intervention will be the dry suction pleural drainage system
Digital pleural drainage system	Digital pleural drainage system	The experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system.

Primary Outcome Measures

Name	Time	Method
length of hospital stay	one year	The primary objective of this study will be the length of hospital stay from the day of surgery until the day of hospital discharge. The average length of hospital stay is 7 days.; A subgroup analysis will be done to determine the impact of a video-assisted operative approach on length of stay and duration of chest tube drainage in comparison to thoracotomy.

Secondary Outcome Measures

Name	Time	Method
duration of chest tube insertion	one year	The duration of chest tube drainage which will also be measured in days from the time of insertion in the operating room until they are removed.

Trial Locations

Locations (1)

Capital Health District Authority; 🇨🇦 Halifax, Nova Scotia, Canada